An inserter for a medical device, where the inserter includes a housing having a first end with an opening therein, an actuator connected to a first gear, an actuator biasing element, a cam gear assembly including a cam member and a second gear, a cam bridge follower in contact with the cam member, and a first plunger assembly having a first plunger and a first biasing element.

A sample collection and testing device for analyzing blood is provided that includes a controller, a fluid flow pathway, a pump configured to move fluid through the fluid pathway, and an optical fluid measurement element configured to measure a light intensity of the fluid in the fluid flow pathway. The controller is configured to: start the pump to move a blood sample in the fluid flow pathway, receive a signal from the optical fluid measurement element indicating a detection of a leading edge of the blood in the fluid flow pathway, stop the pump to stop the moving of the blood in the pathway, receive a plurality of light intensity measurements from the optical measurement element, each light intensity measurement measured at a corresponding point of time, and provide a mapping of the light intensity measurements into an indication of a coagulation of the blood sample over a time period.

An arrangement for producing a sample of body fluid from an opening created in a skin surface at a sampling site including a cartridge with a plurality of compartments and a plurality of sampling sites, and a detector assembly. Each sampling site includes a skin-penetration member having a first end configured to pierce the surface of the skin and an inner lumen in communication with the first end, a spring actuator operatively associated with the skin-penetration member, and a needle hub connecting the skin-penetration member and the spring actuator. The needle hub includes a reagent pad and the spring actuator is configured to drive the skin-penetration member to form the wound opening. Each compartment at least partially encloses the skin-penetration member, the spring actuator, and the needle hub of a respective sampling site.

The present invention includes a system for withdrawing body fluids. The system includes a drive unit having a plunger which is moved from a resting position into a lancing position in order to carry out a lancing process and a lancing unit containing a lancet with a needle. The plunger and lancet are coupled together by a form fit in order to carry out a lancing process. The invention additionally concerns a method for temporarily extending a needle from a device for withdrawing body fluid as well as a lancing unit that can be attached to the drive unit.

A skin pricking device includes a housing having an opening formed in a proximal end thereof; a spring mounted lancet including a needle within a casing having body and cap parts, interconnected by a separable coupling. The cap part has a cap projecting through the opening allow a user to grip and remove the cap. The device further includes a trigger for firing the lancet. Turning the cap part moves the entire lancet, engaging a trigger stop surface on the distal body part of the lancet with a trigger catch and further biasing the trigger to block the lancet. Further turning of the cap part over a second angle relative to the housing causes the cap part to move in a proximal direction by a further, second distance, thereby axially separating the cap part from the body part, whereby the cap part can then be removed from the device.

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

A lancing device has a domed structure that can be depressed by application of a force by a user's finger so as to expose the tip of a needle. The domed structure is configured to move from a non-depressed state to a depressed state in a manner that allows for the piercing of the user's finger. The domed structure may then recoil to its original, non-depressed position upon the user ceasing to apply the force. Other embodiments of a lancing device are disclosed.

A blood lancet device comprising a housing having one end formed as an opening; a sliding sleeve having one end extending from the opening to the outside of the housing; a blood lancet including a needle body and a needle tip arranged at one end of the needle body, the sliding sleeve being bushed at the outside of the housing, said blood lancet adapted to move relative to the sliding sleeve so as to expose the needle tip at the opening; and a biasing member having one end securely fixed with another end of needle body.

Various collection devices, systems and methods relating to the use of devices with open microfluidic channels disposed within a housing defining a lumen. These devices make use of microneedles passed through apertures to induce fluid flow into microfluidic channel networks for collection and analysis. The device can be actuated via button when placed on the skin of a patient to collect a fluid sample, such as a blood draw.